Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICCG/9/91

Study information

Scientific title

An adjuvant randomised study comparing standard dose FE[50]C with a higher dose FE[75]C and evaluating the additional benefit of sequential hormone therapy in node positive pre-menopausal primary breast cancer

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

1. Regimen A: chemotherapy, FE[50]C repeated every three weeks for eight cycles followed by hormonal manipulation.
2. Regimen B: chemotherapy, FE[50]C repeated every three weeks for eight cycles.
3. Regimen C: chemotherapy, FE[75]C repeated every three weeks for eight cycles followed by hormonal manipulation.
4. Regimen D: chemotherapy, FE[75]C repeated every three weeks for eight cycles.

Patient's menopausal status to be assessed post chemotherapy. Pre-menopausal patients randomised to receive hormonal manipulation are to receive a long acting Gonadotrophin Releasing Hormone (GnRH), goserelin or equivalent, every 28 days for three years. Post-menopausal patients randomised to receive hormonal manipulation are to receive tamoxifen 20 mg daily for three years.

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven non-metastatic breast cancer
2. Received optimal axillary node sampling (at least seven nodes must be in the axillary dissection)
3. Between one and five histologically involved axillary nodes
4. Pre-menopausal that is:
a. Last menstrual period within one year of randomisation, or
b. Oestrogen and Follicle Stimulating Hormone (FSH)/Luteinising Hormone (LH) levels compatible with ovarian function, particularly if the patient has had a hysterectomy
5. Adequate renal, hepatic and haematological function
6. No bilateral malignancy
7. No inflammatory breast carcinoma
8. No clinically positive contralateral axillary or supraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumour
9. No ulceration or infiltration of the skin
10. No satellite breast or parasternal nodules
11. No oedema of the arm
12. No medical contraindications to treatment protocols

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Pharmacia Ltd & Upjohn (UK)

Sponsor details

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk

Sponsor type

Industry

Website

http://www.pharmacia.com

Funders

Funder type

Industry

Funder name

Pharmacia and Upjohn (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in: Bliss J, Wils J, Marty M, Coombes G, Lawrence D, Coombes RC, on behalf of the ICCG. Evaluation of the tolerability of FE50C versus FE75C in a prospective randomised trial in adjuvant breast cancer patients. J. Clin. Oncol. 2002;20:15S #2017
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27125966

Publication citations

  1. Results

    Bliss J, Wils J, Marty M, Coombes G, Lawrence D, Coombes RC, on behalf of the ICCG, Evaluation of the tolerability of FE50C versus FE75C in a prospective randomised trial in adjuvant breast cancer patients., J. Clin. Oncol., 2002, 20, 15S, #2017.

  2. Results

    Coombes RC, Kilburn LS, Tubiana-Mathieu N, Olmos T, Van Bochove A, Perez-Lopez FR, Palmieri C, Stebbing J, Bliss JM, Epirubicin dose and sequential hormonal therapy-Mature results of the HMFEC randomised phase III trial in premenopausal patients with node positive early breast cancer, Eur J Cancer, 2016, 60, 146-153, doi: 10.1016/j.ejca.2016.03.001.

Additional files

Editorial Notes

05/05/2016: Publication reference added. 11/01/2016: Publication reference added.